Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Newron Pharmaceuticals SPA
Age
30–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female between the ages of 30 to 80 years with diagnosis of idiopathic Parkinson's Disease of more than 5 years duration, with a Hoehn and Yahr stage of I-IV during an "off" phase.
Be levodopa-responsive and have been receiving treatment with a stable dose of levodopa for at least 4 weeks.
Have motor fluctuations, with \>1.5 hours "off" time during the day. Be able to maintain an accurate and complete diary (18-hour)
You may not be if
Patients with medical conditions and/or taking concomitant medications that would have put them at risk, interfered with the study evaluations, or made them unable to complete the requirements of the study;.
Be in a late stage of Parkinson's Disease, and experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms.
Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months.
Have received treatment with safinamide previously. History of, or current depression psychosis (e.g. schizophrenia or psychotic depression) Evidence of dementia or cognitive dysfunction. History of allergic response to anticonvulsants, levodopa, or other anti-Parkinsonian agents.
Hypersensitivity or contraindications to MAO-B inhibitors. Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy.
Clareo Health | Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa
